PostpartumNCT06560190
Orthopaedic Manual Physical Therapy as Part of the Postpartum Care Continuum
A study testing Orthopaedic Manual Physical Therapy in people with Postpartum and Pregnancy Related, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
Data shows us that injury risk increases in the first year postpartum. There is a paucity of literature regarding MSK injuries in postpartum military women. A unique challenge that postpartum service members face is the increased stress of training for and having to pass a physical fitness test directly tied to their… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum, Pregnancy Related
- What is being tested?
- Orthopaedic Manual Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to 5 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female Active-Duty Service Member
- Postpartum >6 weeks and <6 months
- Cleared by OBGYN at postpartum follow-up to initiate physical activity
Who cannot join
- Current or ongoing treatment by an orthopaedic physical therapist
- Separating from military service in the next 6 months
- Current permanent profile for a musculoskeletal condition
- Peripartum Hysterectomy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Center
San Antonio, Texas, 78234
Casey Shutt-Hoblet, DPT, 210-808-2226, casey.e.shutt-hoblet.mil@health.mil
About this study
Official title: Orthopaedic Manual Physical Therapy as Part of the Postpartum Care Continuum for Active-Duty Service Members
Data shows us that injury risk increases in the first year postpartum. There is a paucity of literature regarding MSK injuries in postpartum military women. A unique challenge that postpartum service members face is the increased stress of training for and having to pass a physical fitness test directly tied to their career advancement.
While there is epidemiological data across multiple branches of service, there is a gap in the literature in terms of how to appropriately address these decreased fitness levels and better understand the root causes. American College of Gynecology (ACOG) recommends that the postpartum visit include actionable information on return to physical activity. However, a large majority of women report receiving no guidance on how to engage in physical activity during pregnancy and in the postpartum period.
Physical therapy is commonly used to help individuals return to physical activity following orthopaedic surgeries, but it is not frequently utilized to assist the postpartum population in progressing back to physical activity. Orthopaedic Manual Physical Therapists (OMPTs) are uniquely trained to address musculoskeletal symptoms and progress physical activity. An OMPT evaluation and treatment could facilitate increased physical activity and improve health-related quality of life, supporting the ACOG recommendation to make postpartum care an ongoing multidisciplinary process.
Read the detailed description
The purpose of this study is to 1) Describe changes in health-related quality of life in postpartum women following eight weeks of orthopaedic physical therapy management as part of the postpartum care continuum for active-duty service members 2) Describe changes in pain and physical activity levels following eight-weeks of OMPT management in this same sample and 3) Determine whether select patient characteristics associated with improvement physical function scores following this same eight-week program of OMPT.
This is a Quasi-experimental one-group repeated measures study. Participants who meet the inclusion criteria will be evaluated by board certified orthopedic physical therapist who is a fellow-in-training.The initial evaluation and treatment will be provided over an 8 week period with a minimum of 3 visits. The treatment approach will be initiated at the initial visit and will be based on standard of care OMPT treatment and existing rehab frameworks for postpartum pelvic girdle pain, low back pain and return to physical activity.
At the 8-week time point, participants will complete final outcomes tools. Participants will be discharged from the study, but they can choose to continue physical therapy intervention with their treating provider if they desire. Data beyond the 8-week mark will not be saved for the research trial.
- Conditions
- Postpartum, Pregnancy Related
- Being tested
- Orthopaedic Manual Physical Therapy
- Keywords
- Postpartum, Physical Activity, Pregnancy, Service Member, Physical Therapy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopaedic Manual Physical TherapyOther
Individualized Treatment
| Study group | Role | What they receive |
|---|---|---|
| Postpartum Study Participant | Experimental | Pragmatic Orthopaedic Physical Therapy Receives: Other: Orthopaedic Manual Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
36-Item Short Form Survey Instrument (SF36)
The 36-Item Short Form Survey Instrument (SF 36) is the most widely used quality of life tool in the postpartum population. The lowest score on each subscale is zero and the highest score on each subscale is 100. A higher score is better.
Measured: Baseline, 4 weeks and 8 weeks
Secondary outcomes (4)
International Physical Activity Questionnaire- Short Form (IPAQ)
We will use the International physical activity questionnaire short form to assess physical activity level. The lowest score is zero and the highest score is not identified although scores over 16 hours of physical activity per day should be excluded as an outlier. A higher score is better.
Measured: Baseline, 4 weeks and 8 weeks
Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) will be used to measure pain.The lowest score is 0 and the highest score is 10. A lower score is better.
Measured: Baseline, 4 weeks and 8 weeks
Cozean Pelvic Dysfunction Screening Protocol
Orthopaedic physical therapists should utilize the Cozean protocol to screen which patients need a pelvic floor rehab referral following the DHA practice recommendation for Pelvic Health and Postpartum Rehabilitation Services. The lowest score is zero and highest score is 10. A higher score does not indicate more dysfunction. A cutoff of 3 is applied to indicate a referral is needed for pelvic floor physical therapy.
Measured: Baseline, 4 weeks and 8 weeks
Edinburgh Postnatal Depression Scale (EPDS)
This tool will be used in accordance with the DHA Practice Recommendation for Behavioral Health Screening and Referral in Pregnancy and Postpartum at the initial evaluation to screen for depression in postpartum patients. The lowest score is zero and highest score is thirty. A higher score is worse and indicates need for behavioral health referral.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start8 Apr 2024
- Primary completion5 Jul 2025 (estimated)
- Study completion5 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Casey Shutt-Hoblet, Brooke Army Medical Center
- Investigators
- Casey Shutt-Hoblet, DPT, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560190
- Sponsor's protocol ID
- PT4Postpartum
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will consider dissemination on a case by case basis.
Publications
Iobst SE, Smith DC, Best NI, Allard RJ, Trego LL. A Scoping Review of Pregnancy, Childbirth, and the Postpartum Period in Active Duty U.S. Military Women. Womens Health Issues. 2021 Aug 25;31 Suppl 1:S81-S92. doi: 10.1016/j.whi.2020.05.005.
PubMed 34454706Miller MJ, Kutcher J, Adams KL. Effect of Pregnancy on Performance of a Standardized Physical Fitness Test. Mil Med. 2017 Nov;182(11):e1859-e1863. doi: 10.7205/MILMED-D-17-00093.
PubMed 29087853Weina SU. Effects of pregnancy on the Army Physical Fitness Test. Mil Med. 2006 Jun;171(6):534-7. doi: 10.7205/milmed.171.6.534.
PubMed 16808137DeGroot DW, Sitler CA, Lustik MB, Langan KL, Hauret KG, Gotschall MH, Gehrich AP. The effect of pregnancy and the duration of postpartum convalescence on the physical fitness of healthy women: A cohort study of active duty servicewomen receiving 6 weeks versus 12 weeks convalescence. PLoS One. 2021 Jul 28;16(7):e0255248. doi: 10.1371/journal.pone.0255248. eCollection 2021.
PubMed 34320030Armitage NH, Smart DA. Changes in Air Force fitness measurements pre- and post-childbirth. Mil Med. 2012 Dec;177(12):1519-23. doi: 10.7205/milmed-d-12-00248.
PubMed 23397699ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
PubMed 29683911Doran F, Davis K. Factors that influence physical activity for pregnant and postpartum women and implications for primary care. Aust J Prim Health. 2011;17(1):79-85. doi: 10.1071/PY10036.
PubMed 21616029Selman R, Early K, Battles B, Seidenburg M, Wendel E, Westerlund S. Maximizing Recovery in the Postpartum Period: A Timeline for Rehabilitation from Pregnancy through Return to Sport. Int J Sports Phys Ther. 2022 Oct 1;17(6):1170-1183. doi: 10.26603/001c.37863. eCollection 2022.
PubMed 36237644Christopher, S.M., et al., Rehabilitation of the Postpartum Runner: A 4-Phase Approach. Journal of Women's Health Physical Therapy, 2022. 46(2): p. 73-86.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthopaedic Manual Physical Therapy as Part of the Postpartum Care Continuum for Active-Duty Service Members
- ClinicalTrials.gov ID
- NCT06560190
- Acronym / sponsor ID
- PT4Postpartum
- Conditions
- Postpartum, Pregnancy Related
- Keywords
- Postpartum, Physical Activity, Pregnancy, Service Member, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 5 Jul 2025 (estimated)
- Study completion
- 5 Jul 2025 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Data shows us that injury risk increases in the first year postpartum. There is a paucity of literature regarding MSK injuries in postpartum military women. A unique challenge that postpartum service members face is the increased stress of training for and having to pass a physical fitness test directly tied to their career advancement.
While there is epidemiological data across multiple branches of service, there is a gap in the literature in terms of how to appropriately address these decreased fitness levels and better understand the root causes. American College of Gynecology (ACOG) recommends that the postpartum visit include actionable information on return to physical activity. However, a large majority of women report receiving no guidance on how to engage in physical activity during pregnancy and in the postpartum period.
Physical therapy is commonly used to help individuals return to physical activity following orthopaedic surgeries, but it is not frequently utilized to assist the postpartum population in progressing back to physical activity. Orthopaedic Manual Physical Therapists (OMPTs) are uniquely trained to address musculoskeletal symptoms and progress physical activity. An OMPT evaluation and treatment could facilitate increased physical activity and improve health-related quality of life, supporting the ACOG recommendation to make postpartum care an ongoing multidisciplinary process.
Detailed description
The purpose of this study is to 1) Describe changes in health-related quality of life in postpartum women following eight weeks of orthopaedic physical therapy management as part of the postpartum care continuum for active-duty service members 2) Describe changes in pain and physical activity levels following eight-weeks of OMPT management in this same sample and 3) Determine whether select patient characteristics associated with improvement physical function scores following this same eight-week program of OMPT.
This is a Quasi-experimental one-group repeated measures study. Participants who meet the inclusion criteria will be evaluated by board certified orthopedic physical therapist who is a fellow-in-training.The initial evaluation and treatment will be provided over an 8 week period with a minimum of 3 visits. The treatment approach will be initiated at the initial visit and will be based on standard of care OMPT treatment and existing rehab frameworks for postpartum pelvic girdle pain, low back pain and return to physical activity.
At the 8-week time point, participants will complete final outcomes tools. Participants will be discharged from the study, but they can choose to continue physical therapy intervention with their treating provider if they desire. Data beyond the 8-week mark will not be saved for the research trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum Study Participant | Experimental | Other: Orthopaedic Manual Physical TherapyPragmatic Orthopaedic Physical Therapy |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female Active-Duty Service Member
- Postpartum >6 weeks and <6 months
- Cleared by OBGYN at postpartum follow-up to initiate physical activity
Key exclusion criteria (4 listed)
- Current or ongoing treatment by an orthopaedic physical therapist
- Separating from military service in the next 6 months
- Current permanent profile for a musculoskeletal condition
- Peripartum Hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthopaedic Manual Physical TherapyIndividualized Treatment | Other | Postpartum Study Participant |
Primary outcome
36-Item Short Form Survey Instrument (SF36)
Time frame: Baseline, 4 weeks and 8 weeks
The 36-Item Short Form Survey Instrument (SF 36) is the most widely used quality of life tool in the postpartum population. The lowest score on each subscale is zero and the highest score on each subscale is 100. A higher score is better.
4 secondary outcomes
International Physical Activity Questionnaire- Short Form (IPAQ)
Time frame: Baseline, 4 weeks and 8 weeks
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, 4 weeks and 8 weeks
Cozean Pelvic Dysfunction Screening Protocol
Time frame: Baseline, 4 weeks and 8 weeks
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 34454706Iobst SE, Smith DC, Best NI, Allard RJ, Trego LL. A Scoping Review of Pregnancy, Childbirth, and the Postpartum Period in Active Duty U.S. Military Women. Womens Health Issues. 2021 Aug 25;31 Suppl 1:S81-S92. doi: 10.1016/j.whi.2020.05.005.
- Background: PubMed 29087853Miller MJ, Kutcher J, Adams KL. Effect of Pregnancy on Performance of a Standardized Physical Fitness Test. Mil Med. 2017 Nov;182(11):e1859-e1863. doi: 10.7205/MILMED-D-17-00093.
- Background: PubMed 16808137Weina SU. Effects of pregnancy on the Army Physical Fitness Test. Mil Med. 2006 Jun;171(6):534-7. doi: 10.7205/milmed.171.6.534.
- Background: PubMed 34320030DeGroot DW, Sitler CA, Lustik MB, Langan KL, Hauret KG, Gotschall MH, Gehrich AP. The effect of pregnancy and the duration of postpartum convalescence on the physical fitness of healthy women: A cohort study of active duty servicewomen receiving 6 weeks versus 12 weeks convalescence. PLoS One. 2021 Jul 28;16(7):e0255248. doi: 10.1371/journal.pone.0255248. eCollection 2021.
- Background: PubMed 23397699Armitage NH, Smart DA. Changes in Air Force fitness measurements pre- and post-childbirth. Mil Med. 2012 Dec;177(12):1519-23. doi: 10.7205/milmed-d-12-00248.
- Background: PubMed 29683911ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
- Background: PubMed 21616029Doran F, Davis K. Factors that influence physical activity for pregnant and postpartum women and implications for primary care. Aust J Prim Health. 2011;17(1):79-85. doi: 10.1071/PY10036.
- Background: PubMed 36237644Selman R, Early K, Battles B, Seidenburg M, Wendel E, Westerlund S. Maximizing Recovery in the Postpartum Period: A Timeline for Rehabilitation from Pregnancy through Return to Sport. Int J Sports Phys Ther. 2022 Oct 1;17(6):1170-1183. doi: 10.26603/001c.37863. eCollection 2022.
- BackgroundChristopher, S.M., et al., Rehabilitation of the Postpartum Runner: A 4-Phase Approach. Journal of Women's Health Physical Therapy, 2022. 46(2): p. 73-86.
- Individual participant dataSharing planned: Undecided. Will consider dissemination on a case by case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Casey Shutt-Hoblet, DPT principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthopaedic Manual Physical Therapy in people with Postpartum and Pregnancy Related, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Casey Shutt-Hoblet, DPT (210-808-2226, casey.e.shutt-hoblet.mil@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
36-Item Short Form Survey Instrument (SF36) (time frame: Baseline, 4 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06560190, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.